(117 days)
Not Found
No
The 510(k) summary describes a synthetic bone void filler material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a bone void filler and bone graft substitute, which directly aids in the healing process of bone defects to restore normal function.
No
Explanation: The device is described as a "resorbable bone void filler" and "bone graft substitute," intended to fill gaps or voids in bone. Its purpose is therapeutic (filling and replacing bone), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states that InQu™ is a sterile, granular, synthetic bone void filler device composed of physical materials (poly (D, L-lactide-co-glycolide) and hyaluronic acid), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- InQu™'s Intended Use: InQu™ is a resorbable bone void filler intended to be implanted directly into the body to fill bony gaps or voids. It is a therapeutic device used in surgical procedures.
- Device Description: The description clearly states it's a "synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid." This is a material intended for implantation, not for testing biological samples.
Therefore, InQu™ falls under the category of a medical device used for treatment and repair within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use as a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
Product codes
MQV
Device Description
InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities and pelvis), spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has confirmed InQu™ is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
Section 5.0 510(k) Summary
| Submitter Name: | ISTO Technologies, Inc. |
|---|---|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200 |
| St. Louis, Missouri 63132 | |
| Contact Person: | Gary Gage |
| Program Director | |
| Phone Number: | 314-995-6049 |
| Fax Number: | 314-995-6025 |
| Date Prepared: | May 22, 2007 |
| Device Trade Name: | InQu™ |
| Device Common Name: | Resorbable bone void filler |
| Classification Name: | Filler, bone void, calcium salt compound |
| Classification Number: | 21 CFR 888.3045 |
| Product Code: | MQV |
| Predicate Device: | InQu™, ISTO Technologies, Inc., K063359 |
| Statement of | |
| Intended Use: | InQu™ is a resorbable bone void filler intended to fill bony gaps or |
| voids that are not intrinsic to the stability of the bony structure. | |
| InQu™ is intended for use as a bone graft substitute in the skeletal | |
| system (extremities and pelvis). InQu™ is indicated for use as a bone |
SEP 17 2007system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
Device Description, InQu™ is intended for single patient use only. InQu™ is a sterile, Summary of granular, synthetic bone void filler device composed of poly (D, L-Technological lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced Characteristics, and with bone during the healing process. Testing has confirmed InQu™ Comparison to the is biocompatible, safe and effective as a general bone void filler device and as a bone graft extender in spine. InQu™ is substantially Predicate Device equivalent to the predicate device in terms of material composition and technological characteristics, and is in fact the same product as the unmodified predicate device, InQu™ (FDA cleared, K063359).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 17 2007
ISTO Technologies, Inc. % Patsy J. Trisler, J.D., Regulatory Consultant 1155 Ollivette Executive Pkwy.- Suite 200 St. Louis, MO 63132
Re: K071428
Trade/Device Name: InQuTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 13, 2007 Received: August 15, 2007
Dear Ms. Trisler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Patsy J. Trisler
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Barbara Buechner
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K071428
Device Name: InQu™
Indications for Use:
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended for use are a bone graft substitute in the skeletal system (extremities and pelvis). InQu™ is indicated for use as a bone graft extender in the spine when combined with bone autograft. These defects may be surgically created or result from traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Seubene BuehuD
(Division Sign-off) for NXM
Division of General, Restorative, and Neurological Devices
510(k) Number K071428